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临床试验/NCT02189200
NCT02189200已完成不适用

Effect of Nutritional Counseling Associated With the Ingestion of Oat Bran in Hypercholesterolemic Subjects in Secondary Prevention

Universidade Federal do Rio de Janeiro1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2012年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
132
试验地点
1
主要终点
Change from baseline in LDL-cholesterol in three months

研究概览

简要总结

Dyslipidemia is among the risk factors for cardiovascular diseases (CVD). Is's due to genetic and / or environmental factors such as inadequate dietary pattern. The occurrence of adverse events with statins, added to recent questions about their benefits on hard outcomes, opens a gap for the importance of seeking other forms of treatment of dyslipidemia, particularly in patients for secondary prevention. The consumption of oat bran, beta-glucan source of dietary fibers with supposed action in reducing the absorption of exogenous cholesterol and the endogenous synthesis of it, and source of avenanthramides, phytochemical compounds with alleged antioxidant in lipid membranes, can be effective strategy for secondary prevention of atherosclerotic disease.

详细描述

Objectives: To evaluate the effect of nutritional counseling associated with the consumption of oat bran (40g per day) in lowering cholesterol, glucose profile and anthropometric parameters of subjects in secondary prevention, evaluate the quality of the diet and the intake of processed foods and ingredients added.

Methods: A randomized block, double-blind, placebo-controlled trial lasting 90 days. Inclusion criteria: individuals aged greater than 20 years, both genders, with LDL-c equal or higher than 130mg/dL fasting lipemia. Eligible individuals were considered using oral lipid-lowering, since the dose reported in the early nutritional intervention was maintained during the study. Exclusion criteria: patients requiring reduction in daily fluid intake, supplement use in dietary fiber and gestation / lactation. Data collected: gender; age; education; drugs; body mass (BM), height, body mass index (BMI), waist circumference (WC), neck circumference (NC); blood pressure; dietary surveys, total cholesterol (TC), LDL-C, HDL-cholesterol (HDL-c), triglycerides (TG), fasting glucose (GLU), fasting insulin (INS), HOMA-IR and QUICK. The diet quality was evaluated at baseline and end of study through the Diet Quality Index Revised (IQD-R). The sample size calculation was performed from a pilot study. It came to the need for 63 subjects for each group, oat bran group (GFAV) and placebo group (GPL). The level of statistical significance was 5% (p <0.05).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •LDL-c equal or higher than 130mg/dL fasting lipemia.

排除标准

  • •patients requiring reduction in daily fluid intake
  • •patients in use of dietary fiber supplements
  • •gestation
  • •lactation

研究组 & 干预措施

Placebo group

Placebo Comparator

refined rice flour (40g per day)

干预措施: refined rice flour- 40g (Dietary Supplement)

Oat bran group

Active Comparator

oat bran (40g per day)

干预措施: oat bran - 40g (Dietary Supplement)

结局指标

主要结局

Change from baseline in LDL-cholesterol in three months

时间窗: mesures assessed in baseline, after 30, 60 and 90 days

次要结局

  • Change from baseline in glucose profile in three months(mesures assessed in baseline, after 30, 60 and 90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Simone Raimondi de Souza

Dra.

Universidade Federal do Rio de Janeiro

研究点 (1)

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